Simone Colgan Dunlap

Helping health care companies navigate regulatory hurdles 

Simone Colgan Dunlap advises on regulatory compliance, related risk management and corporate/contracting matters for a variety of clients, including drug and device manufacturers, pharmacy benefits managers (PBM), third-party administrators (TPA), health care insurers, discount medical plan organizations (including prescription discount card administrators), pharmacies, specialty pharmacies, home health agencies, hospitals, physician organizations, physicians, pharmacists and nurses. She advises on a full range of issues, including:

• Health care agreements
• Health care regulatory compliance
• Health privacy
• Structuring and drafting agreements for novel health care products and services

Simone understands the business needs of health care companies and the constantly shifting regulatory environment in which they operate. She is national chair of the firm's Health & Life Sciences industry team.

• Drafting and negotiating agreements between providers and their business partners, including distribution agreements for drugs and devices, business associate agreements, group purchasing organization agreements, data use agreements, licensing agreements, pharmacy services agreements, specialty pharmacy services agreements, HUB agreements, marketing agreements, Risk Evaluation and Mitigation Strategies (REMS) consulting agreements, independent contractor agreements and numerous other commercial contracts.
• Providing strategic advice to clients on a diverse array of regulatory compliance issues, including investigations and enforcement actions, permitting and licensure, controlled substances distribution and prescription dispensing, FDA compliance, change-of-ownership/mergers and acquisitions, contracting with government payers, review of promotional materials for drug products, medication therapy management programs, federal and state fraud and abuse compliance (e.g., Anti-Kickback Statute and Stark), telemedicine, telepharmacy, compounding, physician-dispensing, clinical trials and records retention.
• Advising on federal health privacy laws, including HIPAA/HITECH, as well as state laws governing the confidentiality of health information, medical records, mental health records and records containing other sensitive information.
• Structuring and drafting agreements for novel products and services.
• Developing template contracts and related procedures for review and negotiation.
• Coordinating and deploying attorney teams to provide short- and long-term customized contracting support during peak work periods, emergencies and for special projects in a manner that integrates the client's contracting preferences.